This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.
Not Provided
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Active Substance: M201-A Route of administration: continuous intravenous injection
Saline Placebo for M201-A Route of administration: continuous intravenous injection
Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE
Sagamihara, Kanagawa, Japan
Number of participants with adverse events as a measure of safety and tolerability
adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures.
Time frame: Throughout the study duration (up to day8)
Pharmacokinetics-Cmax
Observed maximum plasma concentration (Cmax) of M201-A
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-Tmax
Time to Cmax (Tmax) of M201-A
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-AUC0-24
Area under the plasma concentration-time curve from time zero to 24hour of M201-A
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-AUC0-t
-Area under the plasma concentration-time curve calculated from time zero to the last measured time point (AUC0-t) of M201-A
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-AUC0-∞
Area under the plasma concentration-time curve calculated from time zero to infinity (AUC0-∞) of M201-A
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
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Pharmacokinetics-t1/2
Elimination half-life (t1/2) of M201-A
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-CL
Apparent clearance of drug from plasma (CL) of M201-A
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-Vd
Apparent volume of distribution during the terminal phase (Vd) of M201-A
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-E0-24
Amount of drug excreted in urine from time zero to 24hour of M201-A
Time frame: up to 24 hours
Pharmacokinetics-Ae
Urinary excretion rate of M201-A
Time frame: up to 24 hours